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Assessment of Alcon's Ocular Image Quantification System

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ClinicalTrials.gov Identifier: NCT01282138
Recruitment Status : Completed
First Posted : January 24, 2011
Results First Posted : July 25, 2012
Last Update Posted : December 18, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study was to evaluate ocular responses with different allergen provocation methods.

Condition or disease Intervention/treatment Phase
Allergic Conjunctivitis Drug: Olopatadine hydrochloride, 0.1% ophthalmic solution (Patanol) Other: Dextran 70 0.1%, hydroxypropyl methylcellulose 0.3% (Tears Naturale II) Phase 4

Detailed Description:
Subjects demonstrating a successful allergen response to a common allergen received the first study treatment and used as instructed for 5 days, after which they entered the Environmental Exposure Chamber (EEC) for a 3-hour exposure to a known concentration of the allergen. After waiting at least 7 days, subjects received the second study treatment and used as instructed for 5 days, after which a 3-hour Conjunctival Allergen Provocation Test (CAPT) was performed with an escalating concentration of the allergen. Subjects dosed with study treatment approximately 15 minutes prior to each allergen provocation test.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
Official Title: A Study to Assess Alcon's Ocular Image Quantification Using Conjunctival Allergan Provocation Testing (CAPT) and Natural Allergen Exposure in an Environmental Exposure Chamber (EEC)
Study Start Date : December 2010
Primary Completion Date : March 2011
Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Patanol
One drop twice daily in each eye for five days prior to allergen provocation testing, followed by an additional drop in each eye approximately 15 minutes prior to start of testing.
Drug: Olopatadine hydrochloride, 0.1% ophthalmic solution (Patanol)
One drop twice daily in each eye for 5 days, followed by an additional drop in each eye prior to allergen test.
Other Name: Patanol®
Placebo Comparator: Tears Naturale II
One drop twice daily in each eye for five days prior to allergen provocation testing, followed by an additional drop in each eye approximately 15 minutes prior to start of testing.
Other: Dextran 70 0.1%, hydroxypropyl methylcellulose 0.3% (Tears Naturale II)
One drop twice daily in each eye for 5 days, followed by an additional drop in each eye prior to allergen test.
Other Name: Tears Naturale II


Outcome Measures

Primary Outcome Measures :
  1. Change From Baseline in Patient-Assessed Ocular Itching, Environmental Exposure Chamber (EEC), at 3 Hours [ Time Frame: Baseline, 3 hours ]
    As assessed by the participant after 3 hours in the EEC. Ocular itching was graded on a 0-4 scale, where 0=none, 1=tickling sensation involving one or more corners of the eye, 2=all over tickling sensation; 3=moderate continuous itching with desire to rub; 4=severe itching with irresistible urge to rub.

  2. Change From Baseline in Patient-Assessed Ocular Itching, Conjunctival Allergen Provocation Test (CAPT), at 3 Hours [ Time Frame: Baseline, 3 hours ]
    As assessed by the participant after 3 hours of CAPT. Ocular itching was graded on a 0-4 scale, where 0=none, 1=tickling sensation involving one or more corners of the eye, 2=all over tickling sensation; 3=moderate continuous itching with desire to rub; 4=severe itching with irresistible urge to rub.


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • History of allergic conjunctivitis;
  • Active signs and symptoms of ocular allergies;
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • History of dry eye;
  • Presence of ocular infection;
  • Presence of severe or serious ocular conditions;
  • Symptoms of allergic conjunctivitis;
  • Use of topical or systemic ocular medications as specified in protocol;
  • Ocular surgery or laser surgery within 6 months of study start;
  • Unwilling to discontinue contact lens wear 72 hours prior to Visit 1 and during study period;
  • Other protocol-defined exclusion criteria may apply.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01282138


Locations
United States, Texas
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
More Information

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01282138     History of Changes
Other Study ID Numbers: RDG-10-278
First Posted: January 24, 2011    Key Record Dates
Results First Posted: July 25, 2012
Last Update Posted: December 18, 2012
Last Verified: July 2012

Keywords provided by Alcon Research:
Allergic conjunctivitis

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Ophthalmic Solutions
Dextrans
Olopatadine Hydrochloride
Pharmaceutical Solutions
Anticoagulants
Plasma Substitutes
Blood Substitutes
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action